Safety and Efficacy Study of Pirfenidone to Treat Grade 2 or Above Radiation-induced Lung Injury

November 19, 2014 updated by: Beijing Continent Pharmaceutical Co, Ltd.
The purpose of this study is to assess the safety and efficacy of pirfenidone capsules to treat grade 2 or above radiation-induced lung injury patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18-70 years old (include 18 and 70 years), male or female
  2. The pathological diagnosis of lung cancer, with non-small cell lung cancer (NSCLC) staging IIIA or IIIB, and small cell lung cancer (SCLC) in council deadline
  3. General condition assessment, ECOG score of 0-1
  4. Enough heart, liver and kidney function, such as AST, ALT, LDH≤2 times ULN such as plasma total bilirubin, creatinine ≤1.5 times ULN; hematopoietic function enough, such as neutrophils ≥4.0 x109 / L, platelets ≥100 x109 / L
  5. The expected survival at 6 months or more
  6. Subject is able to eat solid food
  7. The initial radical thoracic radiotherapy treatment
  8. The clinical diagnosis of radiation-induced lung injury in Grade 2 or above
  9. The duration of radiation-induced lung injury in less than 1 month
  10. Signed informed consent

Exclusion Criteria:

  1. Radiation-induced lung injury has entered the chronic phase
  2. A history of chronic bronchitis, emphysema, or a history of cor pulmonale
  3. Lung resection surgery
  4. Cancer progression
  5. Pulmonary infection
  6. Associated with other serious diseases: such as occurred within 6 months of myocardial infarction, uncontrolled diabetes etc.
  7. With active peptic ulcer
  8. Pregnant women and patients with mental disease
  9. Those who participate in clinical trials of other drugs within 3 months
  10. Investigator judge does not apply to participate in the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment group
Drug: Pirfenidone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in radiation-induced lung injury classification
Time Frame: 36 Weeks
36 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Continent Pharmaceutical Co, Ltd.

Collaborators

Shanghai Genomics, Inc.
GNI-EPS Pharmaceuticals, Inc. (GNI Group)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

November 18, 2014

First Submitted That Met QC Criteria

November 19, 2014

First Posted (Estimate)

November 20, 2014

Study Record Updates

Last Update Posted (Estimate)

November 20, 2014

Last Update Submitted That Met QC Criteria

November 19, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GNI-F647-1401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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